Cleared Traditional

K892452 - PALASEAL

K892452 is the FDA 510(k) clearance for PALASEAL by Kulzer, Inc.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K892452 · Kulzer, Inc. · Dental device
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Jun 1989
Decision
67d
Days
Class 2
Risk

K892452 is an FDA 510(k) clearance for the PALASEAL(R). Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Kulzer, Inc. (Chicago, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kulzer, Inc. devices

Submission Details

510(k) Number K892452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date June 16, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 127d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 150
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K892452.
LITELINE VLC SOFT RELINE
K895742 · Dentsply Intl. · Dec 1989
CURAY-FORM
K895222 · Scientific Pharmaceuticals, Inc. · Oct 1989
RELIANCE LIGHT CURE RETAINER ACRYLIC
K894564 · Reliance Orthodontic Products, Inc. · Oct 1989
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
TRIAD IMPACT
K863324 · Dentsply Intl. · Sep 1986
ACRYLIC SOLDER
K861239 · Parker Laboratories, Inc. · Apr 1986